Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076870
Company: HIKMA

Products on ANDA 076870

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALLOPURINOL SODIUM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076870

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76870ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2026	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/13/2026	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/09/2016	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 076870

ALLOPURINOL SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALLOPURINOL SODIUM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	212363	GLAND
ALLOPURINOL SODIUM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076870	HIKMA
ALOPRIM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	020298	MYLAN